VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER— 510(k) K140465

Name: FDA 510(k) clearance K140465
Creator: U.S. Food and Drug Administration
Published: 2014-03-20

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K140465 for VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER, Substantially Equivalent on 2014-03-20. Applicant: Ventana Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code NQN
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2014-02-24
Decision date: 2014-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQN

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K140957 — GENASIS HIPATH IHC FAMILY2015-01-15
K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI)2013-11-22
K121516 — VIRTUOSO SYSTEM FOR IHC HER2 (4B5)2013-09-26
K122143 — VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER2013-09-19
K111872 — VIRTUOSO SYSTEM FOR IHC P53 (DO-7)2012-04-19

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Recalls naming K140465

K-number listed on FDA's recall record

Z-0877-2021 — uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001Class II·Terminated·Roche Molecular Systems, Inc.·20201123

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140465.

Data sourced from openFDA. This site is unofficial and independent of the FDA.